Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Led by Hoffmann-La Roche · Updated on 2026-05-01
230
Participants Needed
192
Research Sites
485 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally advanced disease not suitable for curative surgery
- HER2-positive status confirmed by central tumor testing
- PIK3CA-mutated tumor status confirmed by central tumor testing
- Disease-free interval of at least 6 months after completing previous non-hormonal systemic treatment
- Left ventricular ejection fraction of at least 50% as measured by echocardiogram or MUGA scan
- Adequate blood and organ function before starting study treatment
You will not qualify if you...
- Prior treatment with any PI3K, AKT, or mTOR inhibitor or any agent targeting the PI3K-AKT-mTOR pathway for locally advanced or metastatic disease
- Any prior systemic non-hormonal anti-cancer therapy for locally advanced or metastatic HER2-positive breast cancer before induction therapy
- History or active inflammatory bowel disease
- Disease progression within 6 months after receiving any HER2-targeted therapy
- Type 2 diabetes requiring ongoing systemic treatment or any history of Type 1 diabetes
- Active hepatitis B virus infection
- Significant active liver disease including severe impairment, hepatitis, alcohol abuse, or cirrhosis
- Symptomatic active lung disease such as pneumonitis or interstitial lung disease
- History of leptomeningeal disease or carcinomatous meningitis
- Serious infection requiring intravenous antibiotics within 7 days before starting treatment
- Any eye condition requiring medical or surgical intervention to prevent vision loss during the study
- Active inflammatory or infectious eye conditions or history of autoimmune-associated uveitis in either eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 192 locations
1
Banner Health MD Anderson AZ
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
Disney Family Cancer Center
Burbank, California, United States, 91505
Actively Recruiting
3
City of Hope
Corona, California, United States, 92882
Actively Recruiting
4
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
5
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Actively Recruiting
6
Ellison Institute of Technology
Los Angeles, California, United States, 90064
Actively Recruiting
7
Georgetown Uni Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
8
Medstar Research Institute
Hyattsville, Maryland, United States, 20783
Actively Recruiting
9
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
10
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
11
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
12
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
13
Atrium Health
Charlotte, North Carolina, United States, 28209
Actively Recruiting
14
Hightower Clinical
Oklahoma City, Oklahoma, United States, 73102
Withdrawn
15
Renovatio Clinical - El Paso
El Paso, Texas, United States, 79915
Actively Recruiting
16
JPS Health Network
Fort Worth, Texas, United States, 76104
Actively Recruiting
17
Lumi Research
Kingwood, Texas, United States, 77339
Withdrawn
18
Renovatio Clinical
The Woodlands, Texas, United States, 77380
Actively Recruiting
19
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336-7774
Actively Recruiting
20
Swedish Medical Center
Seattle, Washington, United States, 98104-1360
Actively Recruiting
21
Centro de Investigaciones Médicas y Desarrollo LC S.R.L
Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina, C1113AAE
Active, Not Recruiting
22
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, Argentina, C1426AGE
Actively Recruiting
23
Instituto de Oncología de Rosario
Rosario, Argentina, S2000KZE
Actively Recruiting
24
Hospital Provincial del Centenario
Rosario, Argentina, S2002KDS
Actively Recruiting
25
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
San Juan, Argentina, J5400DIL
Actively Recruiting
26
Clínica Viedma
Viedma Rio Negro, Argentina, R8500ACE
Withdrawn
27
Blacktown Hospital
Blacktown, New South Wales, Australia, NSW 2148
Active, Not Recruiting
28
Kinghorn Cancer Centre
Darlinghurst, New South Wales, Australia, 2010
Active, Not Recruiting
29
Gosford Hospital
Gosford, New South Wales, Australia, 2250
Active, Not Recruiting
30
University of the Sunshine Coast
Sippy Downs, Queensland, Australia, 4556
Active, Not Recruiting
31
Monash Health
Clayton, Victoria, Australia, 3168
Completed
32
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia, 6009
Completed
33
Institut Jules Bordet
Anderlecht, Belgium, 1070
Withdrawn
34
CHIREC
Auderghem, Belgium, 1160
Withdrawn
35
CHU Brugmann (Victor Horta)
Brussels, Belgium, 1020
Withdrawn
36
Cliniques Universitaires St-Luc
Brussels, Belgium, 1200
Withdrawn
37
GHdC Site Les Viviers
Charleroi, Belgium, 6000
Withdrawn
38
CHU HELORA - Hôpital de la Louvière - Site Jolimont
Haine-Saint-Paul, Belgium, 7100
Actively Recruiting
39
Jessa Zkh (Campus Virga Jesse)
Hasselt, Belgium, 3500
Withdrawn
40
Clinique Ste-Elisabeth
Namur, Belgium, 5000
Withdrawn
41
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará, Brazil, 60336-232
Actively Recruiting
42
Hospital Sao Rafael - HSR
Salvador, Estado de Bahia, Brazil, 41253-190
Actively Recruiting
43
Hospital Araujo Jorge
Goiânia, Goiás, Brazil, 74605-070
Actively Recruiting
44
Hospital do Câncer de Londrina
Londrina, Paraná, Brazil, 86015-520
Actively Recruiting
45
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, Brazil, 50040-000
Actively Recruiting
46
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
Active, Not Recruiting
47
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Actively Recruiting
48
Hospital de Amor Amazônia
Porto Velho, Rondônia, Brazil, 76834-899
Actively Recruiting
49
Hospital de Cancer de Barretos
Barretos, São Paulo, Brazil, 14784-400
Actively Recruiting
50
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, Brazil, 01246-000
Actively Recruiting
51
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
São Paulo, São Paulo, Brazil, 01317-001
Actively Recruiting
52
Arthur J.E. Child Comprehensive Cancer Center-Calgary
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
53
The Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
Actively Recruiting
54
Eastern Health - General Hospital
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Actively Recruiting
55
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
56
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
57
Hôpital du Sacré-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
Actively Recruiting
58
Centre Hospitalier de l?Université de Montréal (CHUM)
Montreal, Quebec, Canada, PO 25223
Actively Recruiting
59
Hopital du Saint Sacrement
Québec, Quebec, Canada, G1S 4L8
Actively Recruiting
60
Allan Blair Cancer Center
Regina, Saskatchewan, Canada, S4T 7T1
Actively Recruiting
61
Affiliated Hospital of Hebei University
Baoding, China, 071000
Actively Recruiting
62
Beijing Cancer Hospital
Beijing, China, 100142
Actively Recruiting
63
The First Hospital of Jilin University
Changchun, China, 130021
Actively Recruiting
64
Sichuan Provincial Cancer Hospital
Chengdu, China, 610041
Actively Recruiting
65
Sichuan Provincial People's Hospital
Chengdu, China, 610072
Active, Not Recruiting
66
Fujian Cancer Hospital
Fuzhou, China, 350014
Actively Recruiting
67
Zhejiang Cancer Hospital
Hangzhou, China, 310022
Actively Recruiting
68
Harbin Medical University Tumor Hospital
Harbin, China, 150049
Active, Not Recruiting
69
Shandong Cancer Hospital
Jinan, China, 250117
Actively Recruiting
70
The First Affiliated Hospital to Henan University of Science and Technology
Luoyang, China, 471003
Actively Recruiting
71
The Second Affiliated Hospital to Nanchang University
Nanchang, China, 330006
Active, Not Recruiting
72
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, China, 530021
Active, Not Recruiting
73
Shantou Center Hospital
Shantou, China, 515031
Withdrawn
74
Tianjin Cancer Hospital
Tianjin, China, 300000
Actively Recruiting
75
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China, 430022
Actively Recruiting
76
Hubei Cancer Hospital
Wuhan, China, 430079
Active, Not Recruiting
77
Clinica De La Costa
Barranquilla, Colombia, 080020
Withdrawn
78
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
Bogota, D.C., Colombia, 110131
Actively Recruiting
79
Oncomedica S.A.
Montería, Colombia, 230002
Actively Recruiting
80
Sociedad de Oncología y hematología del Cesar Ltda
Valledupar, Colombia, 200001
Actively Recruiting
81
Tampere University Hospital
Tampere, Finland, 33520
Active, Not Recruiting
82
Turku Uni Central Hospital
Turku, Finland, 20520
Active, Not Recruiting
83
Institut Sainte Catherine
Avignon, France, 84082
Actively Recruiting
84
Centre Hospitalier de La Cote Basque
Bayonne, France, 64109
Actively Recruiting
85
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France, 33300
Actively Recruiting
86
Centre Georges Francois Leclerc
Dijon, France, 21000
Actively Recruiting
87
Centre Oscar Lambret
Lille, France, 59020
Actively Recruiting
88
Klinikum St. Marien
Amberg, Germany, 92224
Actively Recruiting
89
HELIOS Klinikum Berlin-Buch
Berlin, Germany, 13125
Actively Recruiting
90
Marienhospital Bottrop gGmbH
Bottrop, Germany, 46236
Actively Recruiting
91
Gynonco Düsseldorf, MVZ Medical Center GmbH
Düsseldorf, Germany, 40235
Withdrawn
92
Frauenarztpraxis Dr. Apel, Dr. Kolpin
Erfurt, Germany, 99084
Actively Recruiting
93
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
94
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, Germany, 79110
Actively Recruiting
95
Klinik & Poliklinik für Frauenheilkunde und Geburtshilfe, Campus Innenstadt
München, Germany, 80336
Actively Recruiting
96
St. Franziskus Hospital Münster;Studiensekretariat der onkologischen Zentren
Münster, Germany, 48145
Actively Recruiting
97
Caritas Klinik St. Theresia -Frauenklinik Brustzentrum
Saarbrücken, Germany, 66113
Actively Recruiting
98
Gynäkologie Kompetenzzentrum
Stralsund, Germany, 18439
Withdrawn
99
Universitätsfrauenklinik Ulm
Ulm, Germany, 89075
Actively Recruiting
100
Queen Mary Hospital
Hong Kong, Hong Kong
Actively Recruiting
101
Tuen Mun Hospital
Hong Kong, Hong Kong
Actively Recruiting
102
Gujarat Cancer & Research Inst.
Ahmedabad, Gujarat, India, 380016
Actively Recruiting
103
Sunshine Global Hospital (A unit of Baroda Medicare Pvt Ltd)
Surat, Gujarat, India, 395007
Actively Recruiting
104
Artemis Hospital
Gurugram, Haryana, India, 122001
Actively Recruiting
105
Sir H. N. Reliance Foundation Hospital and Research Centre
Mumbai, Maharashtra, India, 400004
Actively Recruiting
106
National Cancer Institute
Nagpur, Maharashtra, India, 441108
Actively Recruiting
107
Max Super Speciality Hospital
NEW Delhi Delhi, National Capital Territory of Delhi, India, 110092
Actively Recruiting
108
Tata Medical Center
Kolkata, West Bengal, India, 700160
Actively Recruiting
109
I.R.S.T Srl IRCCS
Meldola, Emilia-Romagna, Italy, 47014
Actively Recruiting
110
Ospedale San Giovanni Addolorata
Rome, Lazio, Italy, 00185
Actively Recruiting
111
Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
112
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, Italy, 20133
Actively Recruiting
113
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, Italy, 20141
Actively Recruiting
114
Ospedale San Gerardo
Monza, Lombardy, Italy, 20900
Actively Recruiting
115
A.O.U. Maggiore della Carità
Novara, Piedmont, Italy, 28100
Actively Recruiting
116
Casa di Cura La Maddalena
Palermo, Sicily, Italy, 90146
Actively Recruiting
117
Ospedale Santa Maria Annunziata
Bagno a Ripoli, Tuscany, Italy, 50012
Actively Recruiting
118
"Azienda Ospedaliera Universitaria Integrata Verona Ospedale Borgo Trento"
Verona, Veneto, Italy, 37124
Withdrawn
119
Nagoya City University Hospital
Aichi, Japan, 467-8602
Actively Recruiting
120
Chiba Cancer Center
Chiba, Japan, 260-8717
Actively Recruiting
121
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Japan, 730-8518
Actively Recruiting
122
Sagara Hospital
Kagoshima, Japan, 892-0833
Actively Recruiting
123
Tokai University Hospital
Kanagawa, Japan, 259-1193
Actively Recruiting
124
Kyoto University Hospital
Kyoto, Japan, 606-8507
Actively Recruiting
125
National Hospital Organization Shikoku Cancer Center
Matsuyama, Japan, 791-0280
Actively Recruiting
126
Saitama Medical University International Medical Center
Saitama, Japan, 350-1298
Actively Recruiting
127
The Cancer Institute Hospital of JFCR
Tokyo, Japan, 135-8550
Actively Recruiting
128
King Hussein Cancer Center
Amman, Jordan, 11941
Actively Recruiting
129
University of Nairobi - Institute of Tropical and Infectious Diseases
Nairobi, Kenya
Actively Recruiting
130
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 44280
Actively Recruiting
131
OncoMed
Mexico City, Mexico CITY (federal District), Mexico, 03100
Actively Recruiting
132
Centro Oncológico Hematológico Roma
Mexico City, Mexico CITY (federal District), Mexico, 06700
Actively Recruiting
133
Hospital Universitario
Monterrey, Nuevo León, Mexico, 64460
Withdrawn
134
CENEIT Oncologicos
Mexico City, Mexico, 03100
Actively Recruiting
135
Sultan Qaboos Comprehensive Cancer Care & Research Center
Muscat, Oman
Actively Recruiting
136
Centrum Onkologii im. Prof. Franciszka ?ukaszczyka
Bydgoszcz, Poland, 85-796
Actively Recruiting
137
Uniwersyteckie Centrum Kliniczne
Gda?sk, Poland, 80-214
Actively Recruiting
138
Szpital Morski im.PCK
Gdynia, Poland, 81-519
Actively Recruiting
139
Narodowy Instytut Onkologii Odzia? w Gliwicach
Gliwice, Poland, 44-102
Withdrawn
140
Przychodnia Lekarska KOMED, Roman Karaszewski
Konin, Poland, 62-500
Actively Recruiting
141
Szpital Wojewódzki im. Miko?aja Kopernika
Koszalin, Poland, 75-581
Actively Recruiting
142
Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie
Późna, Poland, 61-866
Actively Recruiting
143
Centrum Onkologii Instytut im.M. Sklodowskiej-Curie
Warsaw, Poland, 02-781
Actively Recruiting
144
National University Hospital
Singapore, Singapore, 119228
Actively Recruiting
145
National Cancer Centre
Singapore, Singapore, 169610
Completed
146
Icon Cancer Centre Farrer Park
Singapore, Singapore, 217562
Withdrawn
147
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Withdrawn
148
Hopelands Cancer Centre
Hilton, South Africa, 3245
Actively Recruiting
149
Charlotte Maxeke Academic Hospital
Johannesburg, South Africa, 2193
Actively Recruiting
150
Medical Oncology Centre of Rosebank
Johannesburg, South Africa, 2196
Actively Recruiting
151
Limpopo Cancer Research Institute
Polokwane, South Africa, 0700
Actively Recruiting
152
Steve Biko Academic Hospital
Pretoria, South Africa, 0002
Actively Recruiting
153
Chris Hani Baragwanath Clinical Trial Site
Soweto, South Africa, 2013
Active, Not Recruiting
154
National Cancer Center
Goyang-si, South Korea, 10408
Active, Not Recruiting
155
Seoul National University Hospital
Seoul, South Korea, 03080
Active, Not Recruiting
156
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Active, Not Recruiting
157
Asan Medical Center
Seoul, South Korea, 05505
Completed
158
Gangnam Severance Hospital
Seoul, South Korea, 06273
Active, Not Recruiting
159
Samsung Medical Center
Seoul, South Korea, 06351
Active, Not Recruiting
160
Seoul St Mary's Hospital
Seoul, South Korea, 06591
Active, Not Recruiting
161
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, LA Coruna, Spain, 15006
Actively Recruiting
162
Hospital Universitari Dexeus - Grupo Quironsalud
Barcelona, Spain, 08028
Actively Recruiting
163
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
164
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Actively Recruiting
165
Hospital Ramon y Cajal
Madrid, Spain, 28034
Actively Recruiting
166
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Active, Not Recruiting
167
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Spain, 29010
Actively Recruiting
168
Hospital Universitario Virgen Macarena
Seville, Spain, 41009
Actively Recruiting
169
National Taiwan Uni Hospital
Taipei, Taiwan, 100
Actively Recruiting
170
Tri-Service General Hospital
Taipei, Taiwan
Actively Recruiting
171
Chang Gung Memorial Hospital-Linkou
Taoyuan County, Taiwan, 333
Actively Recruiting
172
Abderrahmen Mami Hospital
Aryanah, Tunisia, 2080
Actively Recruiting
173
Taher Maamouri Hospital
Nabeul, Tunisia, 8000
Actively Recruiting
174
Habib Bourguiba Hospital
Sfax, Tunisia, 3029
Actively Recruiting
175
Farhat Hached Hospital
Sousse, Tunisia, 4031
Actively Recruiting
176
Institut Salah Azeiz
Tunis, Tunisia, 1006
Actively Recruiting
177
Sakarya Training and Research Hospital
Adapazarı, Turkey (Türkiye), 54290
Active, Not Recruiting
178
Gulhane Training and Research Hospital
Ankara, Turkey (Türkiye), 06010
Actively Recruiting
179
Gazi University Medical Faculty
Ankara, Turkey (Türkiye), 06500
Actively Recruiting
180
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, Turkey (Türkiye), 34147
Actively Recruiting
181
Dicle University Faculty of Medicine
Diyarbakır, Turkey (Türkiye), 21280
Actively Recruiting
182
Medipol Mega Üniversite Hastanesi Göztepe
Istanbul, Turkey (Türkiye), 34214
Active, Not Recruiting
183
Izmir Ataturk Training and Research Hospital
Izmir, Turkey (Türkiye), 35360
Active, Not Recruiting
184
Medical Park Seyhan Hospital
Seyhan, Turkey (Türkiye), 01140
Active, Not Recruiting
185
Hacettepe Uni Medical Faculty Hospital
Sihhiye/Ankara, Turkey (Türkiye), 06230
Actively Recruiting
186
Uganda Cancer Institute
Kampala, Uganda, 00256
Actively Recruiting
187
Belfast City Hospital
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
188
Blackpool Victoria Hospital
Blackpool, United Kingdom, FY3 8NR
Actively Recruiting
189
Colchester General Hospital
Colchester, Essex, United Kingdom, CO4 5JL
Actively Recruiting
190
Mount Vernon Hospital
Northwood, United Kingdom, HA6 2RN
Actively Recruiting
191
Nottingham City Hospital
Nottingham, United Kingdom, NG5 1PB
Actively Recruiting
192
Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Actively Recruiting
Research Team
R
Reference Study ID Number: WO44263 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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